Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep, Daytime Sleepiness, and Fatigue in Depression
Recruiting · NCT06371352 · Interventional (participants receive a specific treatment) · Lead sponsor: Jakub Antczak
View the official record on ClinicalTrials.gov →Interventions studied
ShamcTBSiTBS
What this trial is about
Intermittent and continuous theta-burst stimulation (iTBS and cTBS respectively) are the newer modalities of transcranial magnetic stimulation with documented efficacy in treatment of depressed mood but with conflicting results regarding their efficacy in treatment of other symptoms of depression such as insomnia, daytime sleepiness and fatigue. This study will investigate the efficacy of iTBS over the left dorsolateral prefrontal cortex (DLPFC) and cTBS over the right DLPFC, compared to sham stimulation, in treatment of insomnia, daytime sleepiness and fatigue in depression.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- severe or moderate depressive episode (according to international classification of diseases (ICD)-10) without psychotic symptoms at the time of inclusion
- Diagnosis of major depression (F33.1 or F33.2) or bipolar disorder (F31.3 or F31.4).
- The score of the Athens Insomnia Scale five or more
- Unchanged antidepressive pharmacotherapy at least one month prior to inclusion
Exclusion criteria
- Contraindications to transcranial magnetic stimulation, including ferromagnetic elements in head, pregnancy and epilepsy
- Psychotic symptoms at the time of inclusion
- Suicidal ideations and/or attempts within three months prior to inclusion
Where it is running
1 location listed.
- Institute of Psychiatry and Neurology - Warsaw, Poland